Glycostem enters contract with Autolomous to digitise manufacturing process
3rd June, 2020 – Autolomous Ltd, a leading edge developer of innovative digital solutions for manufacture of advanced medicines, and Glycostem Therapeutics BV, a clinical stage and leading Natural Killer (NK) cell manufacturing company, today announce the intended implementation of the AutoloMATE platform to digitise the manufacturing and release of Glycostem’s NK-cell therapies for clinical trials and beyond.
“This is an excellent development for Autolomous as we seek to extend our portfolio of users across Europe and the USA and the diversity of products we can support. Glycostem shares our vision of high quality, cost-effective supply chains for cellular medicines and has developed a sophisticated manufacturing process for NK-cells from umbilical cord blood.
This is the first application of the AutoloMATE platform to an allogeneic process which is particularly exciting for us”, said Alexander Seyf, CEO of Autolomous
Autolomous will be implementing the AutoloMATE platform to meet the needs of Glycostem’s allogeneic NK-cell manufacturing process. Driving efficiency throughout the capturing / review and release of manufacturing data. Leveraging leading edge technologies such as distributed ledger technologies, IoT and AI.
“At Glycostem we went through a detailed and comprehensive procurement process with many potential suppliers before final selection of Autolomous as our chosen provider. The AutoloMATE platform will be tailormade for the manufacturing process in our state-of-the-art in-house facility. The broad experience of the Autolomous team gave us confidence in delivery of the product on time to meet our ambitious clinical development schedule and route to the market”, said Troels Jordansen, CEO of Glycostem.
Glycostem expects to start its pivotal clinical trial in AML in 2nd half ’21 in 5 different European countries and 8 clinical centres. It will be the first off-the-shelf cellular immuno therapy NK-cell product entering pivotal trials.